RecruitingNot ApplicableNCT06053606

The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart


Sponsor

Wroclaw Medical University

Enrollment

100 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study examines how using an expandable cryoballoon catheter for pulmonary vein isolation (PVI) — a procedure to treat atrial fibrillation (irregular heartbeat) — affects the heart's autonomic nervous system, which controls the heart's natural pacemaking and rhythm. **You may be eligible if...** - You have paroxysmal atrial fibrillation (episodes that come and go on their own) - You are having your first PVI procedure - You are in normal sinus rhythm at the time of admission - You meet clinical criteria for PVI based on your cardiologist's assessment **You may NOT be eligible if...** - Your left atrium is either too small (less than 38 mm) or too enlarged (greater than 50 mm) - Your heart's pumping function is significantly reduced (ejection fraction below 40%) - You have disease of the heart's natural pacemaker (sinus node disease) - You have advanced heart block or a very long PR interval - You have had a prior cardioneuroablation procedure - You are pregnant, on anticoagulation contraindications, or have other clinical reasons preventing PVI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEcryoablation of atrial fibrillation using only 28 mm size balloon

all applications in all PVs are done with 28 mm balloon

DEVICEcryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

first applications in LSPV and RSPV are done with 31 mm balloon


Locations(1)

Institute of Heart Diseases, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

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NCT06053606


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